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Medicines Classification Committee Medicines Classification Committee Meeting date 1 May 2017 58th Meeting Title Reclassification of Sedating Antihistamines Medsafe Pharmacovigilance Submitted by Paper type For decision Team Proposal for The Medicines Adverse Reactions Committee (MARC) recommended that the reclassification to committee consider reclassifying sedating antihistamines to prescription prescription medicines when used in children under 6 years of age for the treatment of medicine for some nausea and vomiting and travel sickness [exact wording to be determined by indications the committee]. Reason for The purpose of this document is to provide the committee with an overview submission of the information provided to the MARC about safety concerns associated with sedating antihistamines and reasons for recommendations. Associated March 2013 Children and Sedating Antihistamines Prescriber Update articles February 2010 Cough and cold medicines clarification – antihistamines Medsafe website Safety information: Use of cough and cold medicines in children – new advice Medicines for Alimemazine Diphenhydramine consideration Brompheniramine Doxylamine Chlorpheniramine Meclozine Cyclizine Promethazine Dexchlorpheniramine New Zealand Some oral sedating antihistamines available without exposure to a prescription (pharmacist-only and pharmacy only), sedating therefore usage data is not easily available. antihistamines Table of Contents 1.0 PURPOSE ....................................................................................................................................... 3 2.0 BACKGROUND ............................................................................................................................... 3 2.1 Other Information and Recommendations from the 166th MARC meeting ........................ 5 2.2 Previous Cough and Cold Review Group and Medicines Classification Committee Information ................................................................................................................................ 6 2.3 Database of Medicines Classifications ................................................................................. 7 3.0 DATA SHEET INFORMATION ......................................................................................................... 8 Canada product information.................................................................................................... 11 UK product information ........................................................................................................... 12 Australia product information ................................................................................................. 14 US product information ........................................................................................................... 14 4.0 PUBLISHED LITERATURE ............................................................................................................. 17 4.1 Prevention and treatment of motion sickness – Brainard and Gresham (2014) ............... 17 4.2 Antihistamines for the common cold – De Sutter et al. (2015) ......................................... 18 4.3 Safety considerations in the management of allergic diseases: focus on antihistamines – Yanai et al (2012) ..................................................................................................................... 19 4.4 Use of antihistamines in paediatrics – del Cuvillo et al (2007) .......................................... 20 4.5 Safety and tolerability of treatments for allergic rhinitis in children – Baena-Cagnani (2004) 22 4.6 Antihistamines, respiratory depression and the sudden infant death syndrome in young children – a review and recommendations – Scolnik and Koren (1996) ................................. 23 4.7 Night-time sedating H1-antihistamine increases daytime somnolence but not treatment efficacy in chronic spontaneous urticaria: a randomised controlled trial – Staevska et al. (2014) 24 4.8 Adverse central nervous system effects of older antihistamines in children – Simons et al. (1996) 25 4.9 Literature Comments ......................................................................................................... 26 5.0 CARM DATA ................................................................................................................................ 26 6.0 CONCLUSION .............................................................................................................................. 26 7.0 REFERENCES ................................................................................................................................ 28 1.0 PURPOSE At the 166th meeting of the Medicines Adverse Reactions Committee (MARC) the Committee recommended that the Medicines Classification Committee (MCC) consider reclassifying all sedating antihistamines when used in children under 6 years of age for the treatment of nausea and vomiting and travel sickness to prescription medicines. This will not change the classification for use in allergic conditions (ie, will still be available as a pharmacist only medicine for the treatment of allergic conditions in children aged 2 years of age and older). The purpose of this document is to provide the MCC with information about the safety of sedating antihistamines and the reasons for the MARC recommendations for reclassification consideration. Although overall there would still be different age categories for use, dependent upon the indication, this would apply to all oral sedating antihistamines to reduce confusion. A summary of the proposed changes is as follows: Summary table*: Indication Age Allergic conditions (includes hayfever, Pharmacist only medicine for adults and children 2 years of age and older. allergic reactions) Prescription medicine for use in children 2 to 5 years of age (under 6 years old); Nausea and vomiting pharmacy only medicine for adults and children 6 years and older Prescription medicine for use in children 2 to 5 years of age (under 6 years old); Travel sickness pharmacy only medicine for adults and children 6 years and older Contraindicated in children younger than 12 years of age; pharmacist only Insomnia medicine for adults and children 12 years of age and older. Contraindicated in children younger than 6 years of age; pharmacy only Cough and cold medicine for adults and children 6 years of age and older. *All sedating antihistamines contraindicated in children less than 2 years of age. 2.0 BACKGROUND Sedating antihistamines are used for a number of indications, although not all sedating antihistamines are approved for all indications. The range of indications include: - a night time sleep aid for the short-term management of insomnia - the treatment of allergic conditions including some allergic reactions to drugs, urticarial and allergic contact dermatitis, and allergic reactions to insect bites and stings - the relief of excessive secretion in the upper respiratory tract as a result of hayfever and allergic rhinitis - an anti-emetic for vomiting from various causes including post-operative vomiting, irradiation sickness, drug-induced nausea and motion sickness - the relief of vomiting and attacks of vertigo associated with Meniere’s disease and other forms of vestibular disturbance - a premedication for anaesthesia - the relief of runny nose, sneezing, itching of nose or throat, itchy watery eyes due to cold or flu (ie, in cough and cold medicines) The main difference between first (sedating) and second (non-sedating) generation antihistamines is that sedating antihistamines readily cross the blood-brain barrier. Non-sedating antihistamines are highly specific for H1-receptors, are large lipophilic molecules, are extensively albumin-bound, and have little to no anticholinergic, antiserotonergic or anti-alpha-adrenergic effects. Consequently, there are fewer associated adverse reactions with non-sedating antihistamines. The cholinergic activity of first generation antihistamines causes symptoms of drowsiness and reduced concentration, as well as dry mouth, blurry vision and urinary retention1. One of the main concerns with using sedating antihistamines in children is the risk of sedation and respiratory depression. As first generation antihistamines were introduced from 1942 until the mid-1980s, there is a paucity of information relating to potency, efficacy and safety. There are six structural classes of antihistamines, of which both first and second generation antihistamines are included (Table 1). Although characteristic pharmacological properties have been described for each structural class, many of the effects of antihistamines vary from patient to patient2. Table 1: Structural classes of H1 antihistamines2 The efficacy of different H1 antihistamines in the treatment of allergic patients is similar, even when comparing first and second generation antihistamines. However, they are different in terms of chemical structure, pharmacology and toxic potential (although this is also difficult to determine with a lack of study information). 1 Gonzalez MA, Estes KS. Pharmacokinetic overview of oral second-generation H1 antihistamines. International Journal of Clinical Pharmacology and Therapeutics 1998; 36(5): 292–300. 2 Van Schoor J. Antihistamines: a brief review. Prof Nurs Today 2012; 16(5): 16-21 2.1 Other Information and Recommendations from the 166th MARC meeting The MARC considered that the data available indicates that restricting use by age and/or indication is appropriate. See section 4 and 5 below
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